On April 30, 2021 Immunicom, Inc., a clinical-stage biotechnology company pioneering "subtractive" advanced cancer therapies, reported that promising preliminary data from trials investigating ImmunopheresisTM therapy for metastatic, refractory, solid tumor cancer patients who previously failed multiple lines of therapy (Press release, Immunicom, APR 30, 2021, View Source [SID1234578906]). The results presented by Immunicom’s Chief Medical Officer, Dr. Robert Segal, at the 2021 ISFA/E-ISFA virtual joint conference established that Immunopheresis administered to end-stage cancer patients was generally well-tolerated and has the potential for treating refractory malignancies.
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Immunicom’s ongoing clinical trials are in the most difficult to treat, late-stage cancer patients. Immunicom’s novel Immunopheresis therapy uses its proprietary subtractive LW-02 column to selectively remove immune-suppressive cytokines produced by cancer tumors.
"Standard drug treatments are additive therapies that introduce substances into the body to treat cancers. We are developing high-affinity subtractive therapies specifically for these difficult metastatic cancers," said Immunicom’s CEO, Amir Jafri. "Our mission is to define a new era of cancer treatment that is safe and effective."
Dr. Segal’s presentation focused on results from over 600 Immunopheresis procedures conducted in 34 end-stage cancer patients from ongoing clinical trials, demonstrating the viability of this technology as a new treatment strategy. The clinical trials are evaluating the LW-02 column for treating multiple cancers, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. The LW-02 column is being investigated both as a monotherapy and in combination with low-dose metronomic chemotherapy and the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:
Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD;
Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and
Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.
Subtractive Therapy – ImmunopheresisTM and the LW-02 Column
Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy," in contrast to drugs that are "additive." Subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.
Immunicom believes that the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA). Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.
For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.
Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.